Nocturnal EnuresisNCT04620356
Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
A study testing DryNites Pyjama Pants in people with Nocturnal Enuresis, run by Kimberly-Clark Corporation at 2 sites in United Kingdom.
Trial summary
Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- DryNites Pyjama Pants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Feb 2020to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient aged between 4-8 years at the time of enrollment
- Have a clinical diagnosis of monosymptomatic primary NE
- Have been dry in the day for >/= 6 months prior to enrollment
- Have on average no more than 1 dry night per month during the past 6 months at enrollment
- Have an informed consent signed by the their parent(s)/carer(s)
Who cannot join
- Children in foster/court care
- Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for > 7 days in the previous 6 months
- Have secondary NE
- Have wetting in the day
- Have faecal soiling
- Have known urinary tract disease
Show all 10Show fewer
- Have diabetes
- Receive any regular intake of medication
- Have a known developmental/neurological disorder
- Have links to Kimberly-Clark of any kind (including family relations employed by Kimberly-Clark, holding stocks or share in Kimberly-Clark)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Mounts Bay Medical
Connor, Haley, TR27 5DT
Siddarth Marnekar
Hull, HU12 8JD
About this study
Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.
Read the detailed description
Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.
- Conditions
- Nocturnal Enuresis
- Being tested
- DryNites Pyjama Pants
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DryNites Pyjama PantsDevice
DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
| Study group | Role | What they receive |
|---|---|---|
| DryNites arm | Experimental | Participants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night. Receives: Device: DryNites Pyjama Pants |
| No Pants arm | No intervention | Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet Nights
Average number of wet nights
Measured: Last week of the 4-week intervention period
Secondary outcomes (4)
Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)
The PinQ will be used to assess the child's QoL. The PinQ is a validated cross-cultural continence-specific paediatric QoL questionnaire to assess children with bladder dysfunction, developed by Bower el al (Bower et al. 2006). It is available as self-rated and proxy versions.
This will be completed by the child themselves in the older participant group and will be completed by the parent/carer on behalf of the child in the younger participant group.
The PinQ measures the emotional impact that urinary incontinence has on a child. It consists of 20 urinary incontinence QoL related questions divided in 2 dimensions: intrinsic (14 items) and extrinsic (6 items), which are graded on a scale of 0 to 4 (0=No, 1=Hardly ever,2=Sometimes, 3=Often, 4=All the time) with a score range of 0 to 80.
The total score indicates the impact urinary incontinence has on the child's QoL with the higher scores indicating a more significant effect.
Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire
The WHOQoL-BREF questionnaire (WHO 1996) will be completed directly by the parent/carer. . The WHOQoL-BREF questionnaire is derived from a larger instrument, the WHOQoL-100. It includes 26 items, grouped in 4 domains: Physical Heath, Psychological, Social Relationships, and Environment, and 2 separate items asking the crespondent about overall perception of QoL (item 1) and an individual's overall perception of their health (item 2). The scores of items 3, 4 and 5, which are negatively phrased, need to be reversed. The mean score of items within each domain is used to calculate the domain scores, which are converted into a 0-100 scale. Higher scores denote higher QoL. Where more than 20% of data is missing from an assessment, the assessment should be discarded. Where an item is missing, the mean of other items in the domain is substituted. Where more than 2 items are missing from the domain, the domain score should not be calculated
Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Child Daytime Sleepiness as Assessed by PDSS Questionnaire
The Paeditric Daytime Sleepiness Scale (PDSS) questionnaire measures daytime sleepiness in children. It is comprised of 8 items assessing daytime sleepiness and rated on a 5-point scale with 0 = Never and 4 = Always/Very Often. The scale ranges from 0 to 32. The questionnaire will be completed by the child themselves (with attendance of an adult) in the older participant group and by the parent/carer on behalf of the child in the younger participant group. Higher scores indicate greater daytime sleepiness. Higher scores indicate greater daytime sleepiness, and were associated with reduced total sleep time, poorer school achievement, poorer anger control, and frequent illness.
Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)
The CIS questionnaire was used to assess the parents' sleep. It was completed directly by the parent/carer. The CIS consists of 20 statements on fatigue-related problems responders might have experienced in the past 2 weeks. A Likert scoring scheme from 1 to 7 ranging from 1-"no, that is not true" to 7-"yes, that is true" with items 2, 5, 6, 7, 8, 11, 12, 15 and 20 hold inverted scores. The total score ranges from 20 to 140. The questionnaire covers measures 4 dimensions of fatigue: Subjective fatigue severity (8 items), Concentration problems (5 items), Reduced motivation (4 items) and Physical activity (3 items). Dimensions can be analyzed separately, with higher scores indicating higher levels of subjective fatigue (8-56), reduced concentration (5-35), reduced motivation (4-28), and lower levels of physical activity (3-21). A total score over 76 is considered at risk of a fatigue disorder, while 36 provides the cutoff score on the subjective experience of fatigue sub-scale
Measured: Assessment will be done at each study clinic visit (Day 56 +/- 7 )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start21 Feb 2020
- Primary completion28 Jan 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Søren Riting, Principal investigator, Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620356
- Sponsor's protocol ID
- KCC-DN-001
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2020
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breinbjerg A, Kamperis K, Thorsteinsson K, Jorgensen CS, Dossche L, Rayner J, Zhang J, Rodrigues DG, Borch L, Hagstrom S, Tekgul S, Walle JV, Rittig S. Discontinuing absorbent pants in children with bedwetting: a randomized controlled trial. Eur J Pediatr. 2024 May;183(5):2443-2453. doi: 10.1007/s00431-024-05502-w. Epub 2024 Mar 12.
PubMed 38472381
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Use of DryNites Absorbent Pants on the Rate of Spontaneous Resolution of Paediatric Nocturnal Enuresis (NE)
- ClinicalTrials.gov ID
- NCT04620356
- Acronym / sponsor ID
- KCC-DN-001
- Conditions
- Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children vary in the age at which they achieve night-time dryness; in almost all cases children will stop bed-wetting without any need for treatment. Use of absorbent pants for the management of nocturnal enuresis is controversial regarding the impact on the speed at which children become dry throughout the night. The aim of this study is to determine the effect of using DryNites absorbent pants in children with monosymptomatic nocturnal enuresis on the speed they become dry throughout the night compared with removing absorbent pants.
Detailed description
Children with severe monosymptomatic NE between 4 and 8 years of age were recruited from study centers in Denmark, Belgium, and the UK. All participants had used absorbents pandt of any manufacturer for at least the previous 6 months. Participants fulfilling the inclusion criteria entered a 4-week run-in period during which they slept wearing the intervention absorbent pant. To be eligible for randomization, participants needed to have 7/7 wet nights in the last week of the run-in period. Eligible participants were then randomly assigned (2:1) to either discontinuation or continuation of absorbent pants for the 4-week core intervention period. The children sleeping without absorbent pants were permitted to sleep with an absorbent bed mat instead. No behavioral changes such as fluid restriction or lifting the child to the toilet when the parents went to bed were allowed in either group. After completing the core intervention period, participants were invited to take part in a 4-week extension period, during which they would remain on their randomly assigned treatment. Number of wet nights were assesed during the study using an electronic diary. Quality- of- life (QoL) and sleep parameters were assessed using the following validated questionnaires: Paediatric Incontinence Questionnaire (PinQ), World Health Organization Quality of Life Brief Version Paediatric Daytime Sleepiness Scale (PDSS), and Checklist Individual Strength. Questionnaires were completed jointly by children and parents.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DryNites arm | Experimental | Device: DryNites Pyjama PantsParticipants in this arm use DryNites every night for 4 weeks ("run-in" period), an additional 4 weeks (intervention "core trial" period), and an optional additional 4 weeks ("extension" period). All participants in this arm also receive absorbent bad mats to use every night. |
| No Pants arm | No intervention | –Participants in this arm use DryNites every night for 4 weeks only during the initial "run-in" period. Thereafter, participants in this arm do not use DryNites during the 4 week intervention "core trial" period or the optional additional 4 weeks "extension" period. All participants in this arm also receive absorbent bad mats to use every night. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient aged between 4-8 years at the time of enrollment
- Have a clinical diagnosis of monosymptomatic primary NE
- Have been dry in the day for >/= 6 months prior to enrollment
- Have on average no more than 1 dry night per month during the past 6 months at enrollment
- Have an informed consent signed by the their parent(s)/carer(s)
Key exclusion criteria (10 listed)
- Children in foster/court care
- Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for > 7 days in the previous 6 months
- Have secondary NE
- Have wetting in the day
- Have faecal soiling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DryNites Pyjama PantsDryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase. | Device | DryNites arm |
Primary outcome
Wet Nights
Time frame: Last week of the 4-week intervention period
Average number of wet nights
4 secondary outcomes
Impact of Urinary Incontinence on Emotional Wellbeing of Child as Assessed by Paediatric Incontinence Questionnaire (PinQ)
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Impact of Child Nighttime Enuresis on Parent/Carer Quality of Life as Assessed by the WHOQoL-BREF Questionnaire
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Child Daytime Sleepiness as Assessed by PDSS Questionnaire
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7)
Parent/Carer Fatigue as Assessed by Checklist Individual Strength (CIS Questionnaire)
Time frame: Assessment will be done at each study clinic visit (Day 56 +/- 7 )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38472381Breinbjerg A, Kamperis K, Thorsteinsson K, Jorgensen CS, Dossche L, Rayner J, Zhang J, Rodrigues DG, Borch L, Hagstrom S, Tekgul S, Walle JV, Rittig S. Discontinuing absorbent pants in children with bedwetting: a randomized controlled trial. Eur J Pediatr. 2024 May;183(5):2443-2453. doi: 10.1007/s00431-024-05502-w. Epub 2024 Mar 12.
- Individual participant dataSharing planned: No
Related trials for Nocturnal Enuresis
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
Primary Monosymptomatic Nocturnal Enuresis
Active, not recruitingPhase 3
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Stress Urinary Incontinence
Not yet recruiting
Potential Adjuvant Therapies for Children With Primary Nocturnal Enuresis
Nocturnal Enuresis in Children, Primary Nocturnal Enuresis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Riting principal investigator
Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DryNites Pyjama Pants in people with Nocturnal Enuresis, run by Kimberly-Clark Corporation at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wet Nights (time frame: Last week of the 4-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.